A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Safety and Efficacy of LX3305, a Sphingosine-1-Phosphate Lyase Inhibitor, for Treatment of Darier’s Disease or Hailey-Hailey Disease
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10011860Term: Darier's diseaseSystem Organ Class: 100000004850Darier’s Disease or Hailey-Hailey DiseaseMedDRA version: 20.1Level: LLTClassification code 10019029Term: Hailey-Hailey diseaseSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2018-000373-80-FR
- Lead Sponsor
- Dermecular Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 33
1.Male or female =18 years of age.
2.Able to read, understand, and sign the informed consent.
3.Stable health in the opinion of the investigator and as confirmed by medical history with no acute hematologic, renal, neurologic, or liver disease within the past 12 months.
4.Histological diagnosis of Darier’s Disease or Hailey Hailey Disease.
5.Grade 3 (moderate) or Grade 4 (severe) lesions as defined in the IGSA.
6.Willing to abstain from any other medical treatments for HHD or DD while in the study, except as specified in the protocol.
7.Willing and able to participate in the study and to comply with all study requirements, including concomitant medication and other treatment restrictions.
8.Female subjects must have a negative serum pregnancy test at Screening. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months, must agree to use two effective methods of contraception for the duration of the study and at least 1 month after the last dose of study drug. The two forms of contraception authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the following methods of contraception:
•Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
•Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable or implantable
•Intrauterine device (IUD)
•Intrauterine hormone -releasing system (IUS)
•Bilateral tubal; occlusion
•Vasectomized partner (provided that partner is the sole sexual partner and that vasectomized partner has received medical assessment of the surgical success)
•Sexual abstinence (refraining from heterosexual intercourse during the entire study period; the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient)
9.If the subject is a male with a female sexual partner who is of childbearing potential, the couple is willing to use two highly effective methods of birth control during the duration of the trial and for one month after the last dose of study drug. The two forms of birth control authorized are defined as the use of a barrier method of contraception (condom with spermicide) in association with one of the methods of birth control listed in Exclusion Criterion 8.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A participant who meets any of the following criteria will be excluded from this study:
1.Female participant who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study period.
2.Prior treatment as follows:
a.Acitretin =4 weeks prior to study Baseline
b.Alitretinoin =4 weeks prior to study Baseline
c.Any other systemic retinoid =26 weeks prior to study Baseline
d.Systemic corticosteroids =4 weeks prior to study Baseline
e.Systemic antibiotics =2 weeks prior to study Baseline
f.Local treatments such as dermabrasion, laser ablation, or botulinum toxin to the specific skin sites to be monitored during this study =26 weeks prior to study Baseline
3.Participants who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
4.Participants with a past or current medical condition or illness that, in the opinion of the investigator, would compromise their safety during the study or confound study results.
5.Participants with a history of alcohol or drug abuse.
6.Participants with a history of hypersensitivity to any of the excipients of the study drug.
7.Participants who are deprived of liberty by a judicial or administrative decision.
8.Participants who are subject to psychiatric care.
9.Participants admitted to a health or social institution for purposes other than research.
10.Adult participants subject to a legal protection measure (eg, under guardianship or judicial protection).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method